MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEO/INFANT/ADULT DISPOSABLE SP02 SENSOR

Model Number M1133A

Device Problem Device Alarm System (1012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/16/2022

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

It was reported to philips that the philips oximetry probe did not alarm and had a normal value range while the patient was having a "crisis of life".The patient was being monitored by another device that correctly alarmed.There was patient involvement was reported, but there was no harm or an adverse event reported.

Manufacturer Narrative

Complaint evaluation: it is unknown how this issue was resolved.Multiple good faith effort attempts were made to obtain additional information but have been unsuccessful to date.Customer resolution and conclusion: good faith efforts were made to obtain additional information on how this issue was resolved for the customer but have been unsuccessful to date.The resolution is unknown at this time.No further investigation or action is warranted at this time.

Manufacturer Narrative

D1 and d4 correction to product informaiton.H3 and h6: additional information received determined that the issue was with the attached philips m1133a oximetry probe providing a normal value range while the patient was having a "crisis of life".The customer confirmed the issue was not with the mp5 functionality.Functional testing could not be performed m1133a oximetry probe as it was confirmed that the consumables have been disabled and cannot be evaluated.No further investigation is available at this time.

• Brand Name: NEO/INFANT/ADULT DISPOSABLE SP02 SENSOR
• Type of Device: NEO/INFANT/ADULT DISPOSABLE SP02 SENSOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen MA 71034 ; GM 71034
• Manufacturer Contact: hisham alzayat ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15148012
• MDR Text Key: 297214419
• Report Number: 9610816-2022-00403
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 30884838010209
• UDI-Public: 30884838010209
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M1133A
• Device Catalogue Number: M1133A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1